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General information
Not blinded
Double blinded
notbldoubl
1
1
1
1
72
80
7280
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72
72
empty
2022-12-22, 1401/10/01
2022-12-22 00:00:00
empty
2023-12-22, 1402/10/01
2023-12-22 00:00:00
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In practice, changes were made to the exclusion criteria, and the study was conducted double-blind.
In practice, changes were made to the exclusion criteria, and the study was conducted double-blind.
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در عمل تغییراتی در معیارهای خروج ایجاد شد و مطالعه به صورت دوسوکور انجام شد
در عمل تغییراتی در معیارهای خروج ایجاد شد و مطالعه به صورت دوسوکور انجام شد
Endometriosis treated less than 6 months ago with a GNRH agonist or less than 3 months ago danazol or progesterone tablets or less than 1 month ago with oral contraceptives.
Breastfeeding
pregnancy
Cancers of the uterus, ovaries, cervix and high-grade intraepithelial lesions
Endometriosis treated less than 6 months ago with a GNRH agonist or less than 3 months ago danazol or progesterone tablets or less than 1 month ago with oral contraceptives.
Severe pain unrelieved by Cabergoline necessitating the use of other analgesics
lack of willingness to continue in the study
non-adherence to the treatment regimen
any adverse reactions to the medication (particularly allergies)
Sensitivity to the medication and incorrect medication intake in the control group
Endometriosis treated less than 6 months ago with a GNRH agonist or less than 3 months ago danazol or progesterone tablets or less than 1 month ago with oral contraceptives. Breastfeeding pregnancy CancersSevere pain unrelieved by Cabergoline necessitating the use of other analgesics lack of willingness to continue in the uterus, ovaries, cervixstudy non-adherence to the treatment regimen any adverse reactions to the medication (particularly allergies) Sensitivity to the medication and high-grade intraepithelial lesionsincorrect medication intake in the control group
اندومتریوز که تحت درمان با آگونیست GNRH در کمتر از 6 ماه قبل و یا قرص دانازول ویا پروژسترون در کمتر از 3 ماه قبل ویا قرص جلوگیری در کمتر از یک ماه قبل بودند.
شیر دهی
حاملگی
سرطانهای رحم،تخمدان ،سرویکس و ضایعات داخل اپیتلیومی با درجه بالا
اندومتریوز که تحت درمان با آگونیست GNRH در کمتر از 6 ماه قبل و یا قرص دانازول ویا پروژسترون در کمتر از 3 ماه قبل ویا قرص جلوگیری در کمتر از یک ماه قبل بودند.
درد شدید که توسط کابرگولین تسکین نمی یابد و نیاز به استفاده از مسکن های دیگر دارد
عدم تمایل به ادامه مطالعه
عدم پایبندی به رژیم درمانی
هر گونه واکنش نامطلوب به دارو (به ویژه آلرژی)
حساسیت به دارو و دریافت نادرست دارو در گروه کنترل
اندومتریوز که تحت درمان با آگونیست GNRH در کمتر از 6 ماه قبل و یا قرص دانازول ویا پروژسترون در کمتر از 3 ماه قبل ویا قرص جلوگیری در کمتر از یک ماه قبل بودند. شیر دهی حاملگی سرطانهای رحم،تخمدان ،سرویکسدرد شدید که توسط کابرگولین تسکین نمی یابد و ضایعات داخل اپیتلیومی با درجه بالانیاز به استفاده از مسکن های دیگر دارد عدم تمایل به ادامه مطالعه عدم پایبندی به رژیم درمانی هر گونه واکنش نامطلوب به دارو (به ویژه آلرژی) حساسیت به دارو و دریافت نادرست دارو در گروه کنترل
The patient is unaware of the treatment, patients are coded A and B based on random assignment, and the researcher gives the drug to the patient based on patient code A or B. The statistical consultant who analyzes the
The patient is unaware of the treatment, patients are coded A and B based on random assignment, and the researcher gives the drug to the patient based on patient code A or B. The statistical consultant who analyzes the
بیمار از نوع درمان اطلاعی ندارد. بیماران بر اساس تخصیص تصادفی کدبندي A وB می شوند و پژوهشگر براساس کد بیمار Aیا B ،دارو را به بیمار می دهد, مشاور امار که انالیز داده ها را انجام می دهد از گروه بندی بی اطلاع هستند.
بیمار از نوع درمان اطلاعی ندارد. بیماران بر اساس تخصیص تصادفی کدبندي A وB می شوند و پژوهشگر براساس کد بیمار Aیا B ،دارو را به بیمار می دهد, مشاور امار که انالیز داده ها را انجام می دهد از گروه بندی بی اطلاع هستند.
Recruitment centers
#1
Name of recruitment center - English: Imam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا (ع)
Full name of responsible person - English: Elahe Khaleghzadeh
Full name of responsible person - Persian: الهه خالق زاده
Street address - English: Daneshgah street
Street address - Persian: خیابان دانشگاه
City - English: MAshhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: ٩١٣٧٩١٣٣١۶
Phone: +98 51 3854 3031
Fax:
Email: presidentoffice@mums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا (ع)
Full name of responsible person - English: Elahe Khaleghzadeh
Full name of responsible person - Persian: الهه خالق زاده
Street address - English: Daneshgah Street
Street address - Persian: خیابان دانشگاه
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: ٩١٣٧٩١٣٣١۶
Phone: +98 51 3854 3031
Fax:
Email: presidentoffice@mums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza hospital Name of recruitment center - Persian: بیمارستان امام رضا (ع) Full name of responsible person - English: Elahe Khaleghzadeh Full name of responsible person - Persian: الهه خالق زاده Street address - English: Daneshgah streetStreet Street address - Persian: خیابان دانشگاه City - English: MAshhadMashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: ٩١٣٧٩١٣٣١۶ Phone: +98 51 3854 3031 Fax: Email: presidentoffice@mums.ac.ir Web page address:
Protocol summary
Study aim
effect of dopamine agonists (cabergoline) on pain reduction in endometriosis patients.
Design
A clinical trial with control and parallel groups, randomized, phase 3 on 72 patients. The permutation blocks method produced the sequence of randomly allocated people to the studied groups. A random allocation sequence of people was done using Random Allocation Software and a block size of four.
Settings and conduct
patients with endometriosis who refer to the gynecology clinic of Ghaem and Imam Reza (AS) hospitals are included in the study based on inclusion and exclusion criteria. Before starting treatment, on the first day of menstruation, the severity of dysmenorrhea pain in patients is measured using the VAS standard.
Participants/Inclusion and exclusion criteria
inclusion criteria: Diagnosis of clinical endometriosis by observing pain and tenderness in the pelvic examination along with endometriosis nodules in the vaginal examination, firm and motionless uterus and confirmed by ultrasound or MRI (observation of endometriosis cysts and nodules)
Diagnosis of grade I-IV endometriosis based on r-ASRM criteria during diagnostic laparoscopy during the previous 12 months
Dysmenorrhea complaints with EAPP score >30 or >40, normal pap smear. Exclusion criteria: endometriosis who were treated with GnRH agonist less than 6 months ago, or danazol or progesterone pills less than 3 months ago, or birth control pills less than 1 month ago.
Intervention groups
Patients with endometriosis will be given dopamine agonists (cabergoline) 0.5 twice a week for three months and in Contol groups will be given the dingiest 2 milligrams once a day for three months.
Main outcome variables
EAPP on the first day of menstruation and at the end of the first, second, and third month is treatment.
General information
Reason for update
In practice, changes were made to the exclusion criteria, and the study was conducted double-blind.
Acronym
IRCT registration information
IRCT registration number:IRCT20181030041503N6
Registration date:2022-12-20, 1401/09/29
Registration timing:prospective
Last update:2024-12-15, 1403/09/25
Update count:1
Registration date
2022-12-20, 1401/09/29
Registrant information
Name
Malihe Mahmoudinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9878
Email address
mahmoudiniam@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
2022-12-22, 1401/10/01
Actual recruitment end date
2023-12-22, 1402/10/01
Trial completion date
empty
Scientific title
the effect of dopamine agonists (cabergoline) on reducing pain in endometriosis patients
Public title
the effect cabergoline on reducing pain in endometriosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of clinical endometriosis by observing pain and tenderness in the pelvic examination along with endometriosis nodules in the vaginal examination, firm and motionless uterus and confirmed by ultrasound or MRI (observation of endometriosis cysts and nodules)
Diagnosis of grade I-IV endometriosis based on r-ASRM criteria during diagnostic laparoscopy during the previous 12 months
Dysmenorrhea complaint with EAPP score >30 or >40
Normal pap smear
Exclusion criteria:
Endometriosis treated less than 6 months ago with a GNRH agonist or less than 3 months ago danazol or progesterone tablets or less than 1 month ago with oral contraceptives.
Severe pain unrelieved by Cabergoline necessitating the use of other analgesics
lack of willingness to continue in the study
non-adherence to the treatment regimen
any adverse reactions to the medication (particularly allergies)
Sensitivity to the medication and incorrect medication intake in the control group
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the permutation blocks method was used to generate the sequence of random assignments of people to the studied groups. A random allocation sequence of people was done using Random Allocation Software and a block size of four. The permutation block method is one of the random allocation methods in which each block is selected as an integer multiple of the number of studied groups. In this study, there are four blocks: AABB, ABAB, BBAA, and BABA. One of the blocks is randomly selected. If the first block, AABB, is selected, the first and second person will be assigned to group A, and the third and fourth person will be assigned to group B. And this process continues until all samples are allocated. The feature of this method is that the two study groups will have equal numbers. Random Allocation Software is free software for creating a random sequence using scientific methods including the permutation block method for allocating subjects to treatment groups, which was developed by Dr. Mahmoud Saghaei (https://www.saghaei.net).
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is unaware of the treatment, patients are coded A and B based on random assignment, and the researcher gives the drug to the patient based on patient code A or B. The statistical consultant who analyzes the
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad university of medical sciences Ethics committee
Street address
Vice chancellor of Research, Mashhad university of Medical Sciences, Mashhad University of Medical Sciences ,University Avenue.Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-07-02, 1401/04/11
Ethics committee reference number
IR.MUMS.REC.1401.158
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Severe dysmenorrhea pain
Timepoint
On the first day of menstruation and at the end of the first, second and third month of treatment
Method of measurement
By 10-point visual analogue scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with endometriosis who will be given dopamine agonists (cabergoline) 0.5 milligrams twice a week for three months.
Category
Treatment - Drugs
2
Description
Control group: Patients with endometriosis who will be given dingiest 2 milligrams once a day for three month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Elahe Khaleghzadeh
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
presidentoffice@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
malihe mahmoudinia
Street address
Imam Reza Hospital, Imam Reza St., Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3853 4021
Email
mahmoudiniam@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Khaleghzadeh
Position
Specialized assistant for women
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bahonar
City
Mashhad
Province
Razavi Khorasan
Postal code
9178143179
Phone
+98 51 3614 4942
Email
elahekhaleghzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Mahmoudinia
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7, Saremi 24/1 Ave., Hashemieh Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3882 9878
Fax
Email
mahmoudiniam@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Mahmoudinia
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7, Saremi 24/1 Ave., Hashemieh Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3882 9878
Fax
Email
mahmoudiniam@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available